Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System— 510(k) K182468
Substantially EquivalentHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
FDA 510(k) clearance K182468 for Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System, Substantially Equivalent on 2019-03-19. Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.
Clearance details
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Product code
- Code LPH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwah, NJ, US
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.